Blood perfusion device delivery system

ABSTRACT

A delivery system deploys a prosthesis for open surgical repair of a body vessel. The system includes a sleeve to retain segments of a prosthesis in a compressed configuration and retraction members. The sleeve has outer segments associated with each end of the prosthesis. Retraction of the retraction members removes the outer segments of the sleeve from the prosthesis outer ends to allow for expansion of the outer ends of the prosthesis in an outside-in direction. The system can include a handle and an actuation member movably attached to the handle. The actuation member is coupled to the sleeve outer segments so that movement of the actuation member corresponds to removal of the sleeve. The system can include elements to retain the sleeve outer segments to the actuation member and to redirect the retraction members to a direction different from the axis of the prosthesis.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.61/370,304, filed Aug. 3, 2010, which is incorporated herein byreference in its entirety.

BACKGROUND

The preferred embodiments described herein relate generally to medicaldevice delivery systems for open surgical repair of body structures thatdefine body lumens. More particularly, they relate to medical devicedelivery systems for repairing damaged body structures and gaininghemostasis or fluid stability during emergency open surgical medicalprocedures.

Trauma physicians frequently encounter patients having traumatic injuryto a body vessel, such as lacerated vessels or even transected vessels,resulting from gunshots, knife wounds, motor vehicle accidents,explosions, etc. Significant damage to a body vessel may expose apatient to deleterious conditions such as the loss of a limb, loss offunction of a limb, increased risk of stroke, impairment of neurologicalfunctions, and compartment syndrome, among others. Particularly severecases of vascular injury and blood loss may even result in death. Insuch severe situations, the immediate goal is to obtain hemostasis whilemaintaining perfusion of adequate blood flow to critical organs, such asthe brain, liver, kidneys, and heart.

Examples of treatment that are commonly performed by trauma physiciansto treat body vessel injuries include the clamping of the vessel with ahemostat, the use of a balloon tamponade, the ligation of the damagedvessel at or near the site of injury, or the insertion of one or moretemporary shunts. However, conventional surgical repair is generallydifficult with such actively bleeding, moribund patients. In manyinstances, there is simply not enough time to repair the body vesseladequately by re-approximating and suturing the body vessel. In manysituations, the trauma physician will simply insert a temporary shunt(such as a Pruitt-Inahara Shunt) into the vessel. However, use oftemporary shunts has been linked to the formation of clots. This mayrequire returning the patient to the operating room for treatment andremoval of the clots, often within about 36 to 48 hours of the originalrepair. Since shunts are generally placed as a temporary measure torestore blood flow and stop excessive blood loss, the shunt is typicallyremoved when the patient has stabilized (generally a few days later) bya specialized vascular surgeon. After removal, the vascular surgeon willreplace the shunt with a vascular graft, such as a fabric graft that issewn into place. With respect to ligation, ligation of the damaged bloodvessel may result in muscle necrosis, loss of muscle function, or apotential limb loss or death.

Due to the nature of the body vessel injury that may be encountered, theinsertion of shunts or ligation of a blood vessel, for example, oftenrequires that such treatments be rapidly performed at great speed, andwith a high degree of physician skill. Such treatments may occupy anundue amount of time and attention of the trauma physician at a timewhen other pressing issues regarding the patient's treatment requireimmediate attention. In addition, the level of particularized skillrequired to address a vascular trauma may exceed that possessed by thetypical trauma physician. In particular, traumatic episodes to thevessel may require the skills of a physician specially trained toaddress the particular vascular trauma, and to stabilize the patient inthe best manner possible under the circumstances of the case.

Some open surgical techniques utilize sutures to affix damaged tissueportions surrounding fittings that have been deployed with the vessel,which requires the trauma physician to take time to tie the suturesproperly. Although in modern medicine sutures can be tied in relativelyrapid fashion, any step in a repair process that occupies physician timein an emergency situation is potentially problematic. In addition, theuse of sutures to affix the vessel to the fitting compresses the tissueof the vessel against the fitting. Compression of tissue may increasethe risk of necrosis of the portion of the vessel tissue on the side ofthe suture remote from the blood supply. When present, necrosis of thisportion of the vessel tissue may result in the tissue separating at thepoint of the sutures. In this event, the connection between the vesseland the fitting may eventually become weakened and subject to failure.If the connection fails, the device may disengage from the vessel.Therefore, efforts continue to develop techniques that reduce thephysician time required for such techniques, so that this time can bespent on other potentially life-saving measures, and the blood flow ismore quickly restored and damage caused by lack of blood flow isminimized

Trauma physicians generally find it difficult to manipulate a prosthesisfor insertion into a body vessel that has been traumatically injured.For example, one difficulty arises from the trauma physician trying tolimit the size of the opening created for gaining access to the injuredvessel so that such opening requiring healing is as small as possible.Another difficulty is that the injured vessel can be anywhere in thebody, having different surrounding environments of bone structure,muscle tissue, blood vessels, and the like, which makes suchobstructions difficult to predict in every situation and leaves thetrauma physician working with an even further limited access opening.Another potential consideration is the amount of body vessel removedduring a transection. The goal would be to remove a portion of the bodyvessel as small as possible. Yet, a small portion removed from thevessel leaves such a small space between the two vessel portions,thereby making it difficult to introduce the prosthesis between the twovessel portions.

Thus, what is needed is a delivery device for delivering a prosthesisfor use in repair of an injured body vessel, such as an artery or avein, (and in particular a transected vessel) during emergency opensurgery. It would be desirable if such delivery device was easy for atrauma physician to use, and can rapidly introduce a prosthesis into abody vessel, thereby providing a conduit for blood or fluid within theinjured body vessel.

SUMMARY

The problems of the prior art are addressed by the features of thefollowing examples. In one aspect, a delivery system can include asleeve and first and second retraction members. The sleeve can beconfigured to retain segments of a prosthesis in a compressedconfiguration. The sleeve can have a first outer segment and a secondouter segment associated with a first outer end and a second outer endof the prosthesis, respectively. The first retraction member can becoupled to the first outer segment of the sleeve, and the secondretraction member can be coupled to the second outer segment of thesleeve. In response to retraction of the first and second retractionmembers, the first and second outer segments of the sleeve are removedfrom the corresponding outer ends of the prosthesis. Such removal allowsfor the expansion of the outer ends of the prosthesis in an outside-indirection.

In another aspect, the delivery system can include a handle and anactuation member movably attached to the handle. An assembly can bedisposed at a distal end of the handle. The assembly can include asleeve configured to retain segments of a prosthesis in a compressedconfiguration. The sleeve can have a first outer segment and a secondouter segment that are associated with a first outer end and a secondouter end of the prosthesis, respectively. A first retraction member canbe coupled between the first outer segment of the sleeve and theactuation member, and a second retraction member can be coupled betweenthe second outer segment of the sleeve and the actuation member. Inresponse to movement of the actuation member relative to the prosthesisfrom a first position to a second position, the first and second outersegments of the sleeve are removed from the corresponding outer ends ofthe prosthesis. This removal allows for the expansion of the outer endsof the prosthesis in an outside-in direction. The handle may include aguiding member to redirect the retraction members from a directiongenerally along the longitudinal axis to a direction different from thelongitudinal axis, such as along the translational axis of the actuationmember, which is generally perpendicular to the longitudinal axis. Theactuation member may include a retaining member configured to removablyattach with each of the retraction members.

Further, in another aspect, a method of open surgical repair of a bodyvessel is provided. The method can include one or more of the followingsteps, including inserting a first outer end of a prosthesis in a firstvessel portion of a body vessel. The first outer end of the prosthesiscan be retained in a compressed configuration by a sleeve portion. Asecond outer end of the prosthesis can be inserted in a second vesselportion. The second outer end of the prosthesis can be retained in acompressed configuration by a sleeve portion. The sleeve portions can becomposed of a single sleeve or multiple sleeves. Sleeve portions can beremoved from the respective first and second outer ends of theprosthesis. The first and second outer ends of the prosthesis can beallowed to move to an expanded configuration for engagement with thecorresponding vessel portion of the body vessel. In one example, thesleeve portions can be removed with application of an activation agentconfigured to rapidly weaken or to dissolve the sleeve portions.

BRIEF DESCRIPTIONS OF THE DRAWINGS

FIG. 1A is an elevation view of an example delivery system having aprosthesis retained in a compressed configuration by a removable sleeve.

FIG. 1B is an end view of the system of FIG. 1A.

FIGS. 2A-2B are elevation views of the system FIG. 1A, depictingoperation of the system for removal of the sleeve from the prosthesis.

FIG. 3A is a perspective view of an example delivery system, and inparticular, a system for use with the delivery system of FIG. 1A.

FIG. 3B is a cross-sectional view of the system of FIG. 3A taken alongline 3B-3B.

FIG. 3C is a perspective view of a distal end of the system of FIG. 3A,depicting a guiding element.

FIG. 3D is a cross-sectional view of the system of FIG. 3C taken alongline 3D-3D.

FIG. 4A is a perspective view of a partial distal end of the system ofFIG. 3A, depicting a handle body with a sharp edge.

FIG. 4B is an end view of the distal end of the system of FIG. 4A,depicting a sharp edge of the handle body with a distal tip in dashedlines.

FIGS. 5A-5E illustrate a method of open surgical repair of a body vesselwith a delivery system deploying a prosthesis.

FIG. 6A is an elevation view of another delivery system for deploying aprosthesis, depicting a removable sleeve that can dissolve.

FIGS. 6B-6E are partial elevation cross-sectional views of a damagedbody vessel, depicting alternative method steps of deploying aprosthesis using the system of FIG. 6A.

DETAILED DESCRIPTION OF THE DRAWINGS AND THE PRESENTLY PREFERREDEMBODIMENTS

For the purposes of promoting an understanding of the principles of theinvention, reference will now be made to the embodiments illustrated inthe drawings, and specific language will be used to describe the same.It should nevertheless be understood that no limitation of the scope ofthe invention is thereby intended, such alterations and furthermodifications in the illustrated device, and such further applicationsof the principles of the invention as illustrated therein beingcontemplated as would normally occur to one skilled in the art to whichthe invention relates. Throughout the specification, when referring to amedical device, or a portion of a medical device, the terms “distal” and“distally” shall denote a position, direction, or orientation that isgenerally towards, or in the direction of, the patient when the deviceis in use. The terms “proximal” and “proximally” shall denote aposition, direction, or orientation that is generally away from thepatient, or closer to the operator, during use of the device. It isunderstood that like-referenced numerals are used throughout the Figuresto designate similar components.

The delivery system described herein can deploy a prosthesis that isuseful for repair of body structures that define lumens, ducts, orpassageways of the body, with the term “body vessel” used in thespecification to describe theses structures in general, during emergencyopen surgical repair. In one example, the prosthesis can be particularlyuseful for repair of a lacerated or transected body vessel duringemergency open surgery, and particularly, to obtain hemostasis or fluidstability while maintaining blood perfusion or fluid flow. While someprosthetic devices are only implanted temporarily for treatment, theprosthesis can be implanted permanently thereby obviating the need forfurther surgical intervention and repair. In one application withrespect to a blood vessel, blood vessels are of two types, namelyarteries and veins. Generally speaking, arteries are elastic vesselsthat carry oxygenated blood away from the heart, and veins are elasticvessels that transport blood to the heart and that then transport bloodto the lungs for oxygenation. The walls of both arteries and veinsgenerally consist of three layers or tunics. The inner layer is referredto as the tunica intima, which is composed of endothelium and delicatecollagenous tissue. The middle layer is referred to as the tunica media,which is composed of typically a muscular layer, and consists of smoothmuscle and elastic fibers. The outer layer is referred to as the tunicaadventitia, which is the outer covering of the vessel, and is composedof connective tissue, collagen, and elastic fibers. The tunic adventitiaincludes small vessels, referred to as vasa vasorum, which supplynutrients to the tissue. Preferably, the prosthesis controllablyinteracts with the tunica intima, basement membrane, and tunica media,and avoids interaction with the tunica adventitia to not disrupt thevasa vasorum residing in the tunica adventitia. The prosthesis can besecured in a rapid manner without the use of a ligature or suture placedaround the vessel.

FIGS. 1A-1B depict one example delivery system 10 including a prosthesis15 (shown in dashed lines) retained in a radially compressedconfiguration by a removable tubular sleeve 30. The removable sleeve 30may be fitted at least partially over the first and/or second outer ends18, 19 of the prosthesis 15 to selectively retain the outer ends in thecompressed configuration for insertion into an end opening of the avessel. As shown in the figures, the removable sleeve 30 may be composedof a single sleeve configured to retain the entire prosthesis from thefirst end 18 to the second end 19 of the prosthesis 15. In anotherexample, the removable sleeve 30 may include two discrete sleeveportions (not shown). Here, the removable sleeve includes a first sleeveportion retaining a first outer segment of the prosthesis 15 associatedwith the first outer end 18, and a second sleeve portion retaining asecond outer segment of the prosthesis 15 associated with the secondouter end 19, leaving an intermediate segment between the first andsecond outer segments unretained by the removable sleeve.

The removable sleeve 30 can be everted or folded at a point of eversion33A, 33B proximate the outer ends 18, 19 of the prosthesis 15 and bedirected toward a middle 34 of the prosthesis. This arrangement can forma radially inner layer 36 and a radially outer layer 38 of the sleeve 30and allows the ends of the outer layer to gather toward the prosthesismiddle 34. In one example, the outer layer 38 and the inner layer 36 aretwo separate tubular members that are coupled to one another by anattachment mechanism, such as by adhesives, soldering, welding, sewingor other common attachment mechanisms. The inner layer 36 can directlycontact the prosthesis 15 to extend along at least partially a segmentof the prosthesis. The outer layer 38 can extend from the outer end ofthe inner layer 36 to a more intermediate portion of the inner layer.The inner and outer layers may slidably interact with one another duringretraction of the outer layer ends. To this end, a lubricious coatingmay be applied to suitable portions of the layers to facilitate theirinteraction. The lubricious coating can be a fluoropolymer of the typecommonly used to impart lubricity to a medical device, and mostpreferably, polytetrafluoroethylene (PTFE).

In one example, the sleeve 30 may be pre-split in order to facilitatemechanical removal of the sleeve from the prosthesis. In a pre-splitsleeve, any number of splits 45 can be pre-formed in the outer layerfrom the outer layer end toward an intermediate portion proximate theeversion points 33A, 33B. Having a solid outer layer material betweenthe eversion point and the beginning of the split forms a sold ring 47of material around the ends of the prosthesis, which preferably overlaysthe anchoring members of the prosthesis. The solid ring 47 can comprisethe outer layer and the inner layer together forming a double layer ofmaterials to enhance the retention of the outer ends of the prosthesisto the compressed configuration.

The outer layer and its ends can be manipulated and retracted by the enduser to remove the sleeve from the prosthesis. To this end, the systemcan include at least two retraction members associated with the outerends of the prosthesis. The first and second retraction members can beindependently retractable. FIG. 1A shows four splits that form the fourouter layer ends, although two or three or more outer layer ends may beformed. The four outer layer ends can define first and third retractionmembers 46A, 46C associated with the first outer end 18 of theprosthesis 15 and second and fourth retraction members 46B, 46Dassociated with the second outer end 19 of the prosthesis 15. The endsof the retraction members can be enlarged or have an enlarged knob 48attached thereto to facilitate gripping and manipulation of the sleeve30 during removal from the prosthesis. The retraction member is operablefor peeling and/or splitting the sleeve 30 from the respective outerends 18, 19 toward the middle 34 of the prosthesis 15 to allow forexpansion thereof In one example, the retraction member and theremovable sleeve are formed integrally from a single tubular piece ofsleeve material. Here, the outer end of the tubular sleeve is evertedalong the prosthesis so that the everted portions form the retractionmember. Alternatively, the retraction member may be a discrete memberfrom the sleeve. Here, the retraction member may be composed of sleevematerial and/or a tension member, such as a wire or a filament ofbiocompatible metal or plastic. The discrete retraction member can havea first end attached to the outer end of the removable sleeve and asecond end that is accessible by the end user.

A concise description of the prosthesis 15 will now be provided. Oneexample of a prosthesis is described in U.S. patent application Ser. No.______, filed on Aug. 3, 2011, entitled “BLOOD PERFUSION DEVICE,” whichis incorporated herein by reference in its entirety. The prosthesis 15can include a generally tubular graft body and/or one or more anchoringmembers 49 and/or supporting members together defining a fluidpassageway. The prosthesis 15 is movable between the radiallycompressed, delivery configuration and the radially expanded, deployedconfiguration. The prosthesis can be balloon expandable; however, it ispreferred that the prosthesis is self-expandable. The anchoring membersand/or supporting members can be attached to the graft body by suturessewn therein, wire, staples, clips, bonding agents, or other methodsthat may be used to achieve a secure attachment to the graft body. Theprosthesis has a size and shape suitable for at least partial placementwithin a body vessel, such as an artery or vein, and most particularly,for placement at the site of a vascular trauma. The prosthesis may beeasily manipulated during delivery to a body vessel such as a transectedartery or vein during emergency surgery, and particularly, to obtainhemostasis while maintaining blood perfusion. The anchoring memberand/or supporting member can be any stent pattern known to one skilledin the art. Examples of stent patterns is the Z-STENT® and ZILVER®stent, each available from Cook Medical Inc. (Bloomington, Ind.). Theanchoring member and/or supporting member can be formed of abiocompatible metal, such as stainless steel (e.g., 316L SS), titanium,tantalum, nitinol or other shape memory materials, or a high-strengthpolymer. Preferably, the anchoring member 49 can provide vesselfixation, while preferably avoiding adverse conditions associated withdisturbing the vasa vasorum and/or pressure induced necrosis of themedium muscular arteries of the type that may result from tyingligatures circumferentially around a connector or a vascular conduit.The anchoring member 49 can include various shaped member structures,including barbs, fibers, bristles, or outer protruding and penetrablemedia.

The graft body can be formed from conventional materials well known inthe medical arts. The graft body may comprise an expandedpolytetrafluoroethylene (ePTFE), polytetrafluoroethylene, silicone,polyurethane, polyamide (nylon), as well as other flexible biocompatiblematerials. The graft body can also be formed from known fabric graftmaterials such as woven polyester (e.g. DACRON®), polyetherurethanessuch as THORALON® from Thoratec Corporation (Pleasanton, Calif.),polyethylene such as an ultra-high molecular weight polyethylene(UHMwPE), commercially available as DYNEEMA®. The graft body may alsoinclude a bioremodelable material, such as reconstituted ornaturally-derived collagenous materials, extracellular matrix material(ECM), submucosa, renal capsule membrane, dermal collagen, dura mater,pericardium, fascia lata, serosa, peritoneum or basement membranelayers, intestinal submucosa, including small intestinal submucosa(SIS), stomach submucosa, urinary bladder submucosa, and uterinesubmucosa. One non-limiting example of a suitable remodelable materialis the SURGISIS® BIODESIGN™, commercially available from Cook MedicalInc. (Bloomington, Ind.). Another suitable remodelable material is thegraft prosthesis material described in U.S. Pat. No. 6,206,931 to Cooket al., which is incorporated herein by reference in its entirety.

Portions of the prosthesis can also include a coating of one or moretherapeutic agents along a portion of the stent structure and/or thegraft body. Therapeutic agents for use as biocompatible coatings arewell known in the art. Non-limiting examples of suitable bio-activeagents that may be applied to the vascular conduit includethrombo-resistant agents, antibiotic agents, anti-tumor agents,antiviral agents, anti-angiogenic agents, angiogenic agents,anti-mitotic agents, anti-inflammatory agents, angiostatin agents,endostatin agents, cell cycle regulating agents, genetic agents,including hormones such as estrogen, their homologs, derivatives,fragments, pharmaceutical salts and combinations thereof. Those skilledin the art will appreciate that other bioactive agents may be appliedfor a particular use. The bioactive agent can be incorporated into, orotherwise applied to, portions of the vascular conduit by any suitablemethod that permits adequate retention of the agent material and theeffectiveness thereof for its intended purpose. Although the device hasbeen described in connection with its primary intended use for repair ofvascular trauma, those skilled in the art will appreciate that thedevice may also be used to repair other traumatic conditions.Non-limiting examples of such conditions include aneurysms, such asabdominal aorta aneurysms, and surgery for tumor removal.

The sleeve 30 can be made of any material that is biocompatible andsuitable to retain the prosthesis in the radially compressed configuredand yet still capable of being peeled from the prosthesis and/or split.It is desirable that the sleeve is made from materials that are thin aspossible to reduce the overall delivery profile of the system. Forexample, the sleeve can be extruded from a biocompatible polymermaterial. In addition, the sleeve can be formed of at least one layersuch as a polyether block amide, nylon, polyurethane,polytetrafluoroethylene (PTFE), FEP, or any combination thereof In oneexample, the sleeve can be removed from the prosthesis withoutsplitting. In another example, the sleeve can be configured to beseparated, preferably longitudinally, along a relatively predictablepath. The material of the sleeve is configured to be split or cut intotwo or more portions by movement of the sleeve alone relative to theprosthesis and/or movement of the sleeve against a handle portion,thereby opening a fissure along the length that permits its removal fromaround the prosthesis situated therein. A predetermined split line maybe formed in the sleeve through which the tear or split progresses dueto properties of, and/or features incorporated into the material. Whenpresent, the predetermined split line can withstand being subjected to acurve to the degree required by the particular application withoutkinking or premature separation. In one example, the sleeve can comprisea splittable polymer such as molecularly oriented, non-isotropic PTFEthat is used to make the PEEL-AWAY® Introducer Sheath, which iscommercially provided by Cook Medical Inc. (Bloomington, Ind.). Suchsleeve is described in, e.g., U.S. Pat. No. 4,306,562 to Osborne andU.S. Pat. No. 4,581,025 to Timmermans, each of which is incorporatedherein by reference in its entirety. In other examples, the sleeve caninclude one or more preweakened features, such as a score line,perforations, or reduced wall thickness regions, extendinglongitudinally along the length of the sleeve.

FIGS. 2A-2B show an example method of removing the sleeve 30 from theprosthesis 15 in order to allow the prosthesis to radially expand. InFIG. 2A, the delivery system 10 can be reoriented such that theretraction members 46A-46D are gathered toward the prosthesis middle 34at a single side 50 of the system 10. This arrangement places some ofthe splits 45 on another side 52, opposite the side 50. Typically, atrauma pathway is formed in the body in order to gain access to thedesired body vessel. One or both ends 18, 19 of the prosthesis retainedby the sleeve can be inserted within the body vessel, as describedbelow. According to FIG. 2B, the retraction members 46A-46D can be movedrelative to the side 52, in a radial direction represented by arrow 54within the trauma pathway, to cause a portion of the sleeve 30 tofurther peel or separate the splits 45 (i.e., increase the length of thesplits). This action removes a portion of the sleeve 30 away from theouter ends 18, 19 from an outside-in direction in order to allow forradial expansion of the prosthesis 15 at its ends 18, 19, where theanchor members 49 can engage the body vessel wall. The sleeve 30 can befirst removed along the surface of the prosthesis in the outside-indirection along the outer surface of the prosthesis initially beforebeing moved in the radial outward direction 54. As can be appreciated bythose skilled in the art, the retraction members can be moved relativeto the side 52 until the sleeve 30 is entirely removed from theprosthesis. To facilitate removal, a force or a structure 56 can beplaced approximately at the prosthesis middle 34 for leverage as thesleeve is being removed. The retraction members are pulled in theretraction direction until the sleeve is entirely removed from theprosthesis. The expansion force of the prosthesis may facilitate thepeeling and/or splitting of the sleeve during the removal process.

FIG. 3A depicts a delivery tool 100 that may be utilized with the system10, as will be further explained, to define another delivery system 200,as shown, e.g., in FIG. 5B. The tool 100 can include a handle 101 havinga proximal end 102 and a distal end 104. The proximal end 102 can beshaped and sized to fit within a palm of the end user. The distal end104 can be shaped and sized to engage the system 10 to define thestructure 56 in FIG. 2B, e.g., at the prosthesis middle 34. In oneexample, the distal end 104 may include a contoured tip 106 shaped tofit around the rounded surface of the prosthesis. For example, the tip106 can have a concave curvature or a saddle shape that is sized toreceive the curvature of a portion of the system 10, which includes thesleeve and the prosthesis.

An actuation member 108, such as, e.g., a lever, can be attached to thesystem handle 101, which can be moved relative to the handle between afirst position and a second position along a translation axis TA. Theactuation member 108 may be configured to move and cause simultaneous orsequential expansion of the outer ends of the prosthesis. In oneexample, the actuation members 108 is in the form of a lever shownslidably attached within a slot 109 that is formed approximately throughthe center of the handle 101. The actuation member 108 may be configuredto allow for simultaneous expansion of the outer ends of the prosthesis.However, the actuation member may be configured to allow for sequentialexpansion of the outer ends of the prosthesis, such as, e.g., having amovable left portion associated with the first outer end and a movableright portion associated with the second outer end. The slot 109 may bean open slot extending entirely through the handle so that access to theopen slot is available from opposite sides of the handle. The slot 109may be a closed slot or a groove formed in opposite sides of the handle,which are not in communication with one another. The slot 109 canprovide a guiding channel for the movable actuation member and its endsmay function as physical stops to define the first and second positionsof the actuation member 108. The slot 109 can be dimensioned so that,when the actuation member 108 is at the first position (e.g., at thedistal end 110 of the slot 109), the sleeve 30 can retain the prosthesisin the radially compressed configuration. When the actuation member 108reaches the second position (e.g., the proximal end 111 of the slot109), the sleeve 30 can be removed sufficiently to allow at least theouter ends of the prosthesis to expand to the radially expandedconfiguration. Preferably, when the actuation member 108 reaches thesecond position, the sleeve 30 can be removed entirely from theprosthesis. The lever 108 may include contoured portions for betterreceiving the fingers of the end user.

The sleeve 30 can be coupled to the actuation member 108 in such amanner such that movement of the actuation member can change thepositioning of the sleeve relative to the prosthesis. For example, thesleeve portions, such as, e.g., the retraction members, can be attachedin a secured relationship with the actuation member by a variety ofattachment mechanisms, such as clamps, mechanical fasteners, adhesives,welding, soldering, sewing, or attachment mechanisms. The coupling canenhance the removal of the sleeve from the prosthesis. It can alsoensure that the retraction member and/or the sleeve remain attached tothe tool 100, so that removal of the tool 100 from the body directlycorresponds to removal of the retraction member and/or the sleeve fromthe body as well. Each of the retraction members can be coupled to thefirst outer segment of the sleeve at a first attachment point and to theactuation member at a second attachment point that is closer inproximity to the middle of the prosthesis.

In one example, the sleeve 30 can be removably attached to the actuationmember 108, e.g., by threaded engagement, removable clamps, ormechanical fasteners. For instance, the actuation member 108 can beconfigured to receive the ends of the retraction members for removableattachment therewith. In one aspect, the actuation member 108 mayinclude a retaining member 120. The retaining member 120 can be attachedto the actuation member 108, e.g., to opposite surfaces 121 of theactuation member. The member 120 can include a notch 122 configured toreceive a portion of the retraction members. A front opening 124 may beformed in the retaining member that is in communication with the notch122 to allow the retraction member to pass selectively therethrough.

The retaining member 120 can be a variety of shapes. In one example, theretaining member 120 includes a pair of “L”-shaped elements, having afirst leg extending out from the surface 121 of the actuation member 108and a second leg extending toward the middle. The retaining member 120can be positioned relative to one another such that the ends of thesecond legs are spaced from one another to define the front opening 124.It is preferable that the notch 122 and/or the front opening 124 aresized to receive the ends of the retraction members, but sized smallerthan the enlarged ends. This arrangement can facilitate the retention ofthe sleeve and/or the retraction member by the retaining member when theactuation member is moved relative to the prosthesis. The retainingmember can cooperatively confine the retraction member into the notchsuch that the retraction member is prevented from falling out in thedirection of the first leg and/or the direction of the second leg. Theretaining member 120 can allow for easy attachment and removal of theends of the retraction members so that the delivery tool 100 can be usedand/or reused for a variety of prosthesis sizes. With the ends of theretraction members retained by the actuation member, movement of theactuation member in a proximal direction toward the second position,facilitates relative movement between the sleeve and the prosthesis tocause a portion of the sleeve to further peel or separate the splits.

FIG. 3B illustrates that the actuation member 108 may be configured tosurround the handle 101. In one example, the actuation member 108 mayhave a channel 130 formed therein along the translational axis and sizedto receive the handle 101. The retaining member 120 can be on eitherside or both sides of the actuation member 108. A connecting member 132coupling both sides of the actuation member 108 can be extended throughthe slot 109. The connecting member 132 can traverse within the slot 109when the actuation member is being moved between the first position andthe second position.

FIGS. 3C-3D illustrate that the tool 100 may include a guiding element135 that is configured to facilitate the transition of the retractionmember from a horizontal direction in the figures, such as along thelongitudinal axis of the prosthesis, to a different direction, such asalong the translational axis or vertical direction in the figures. Theguiding element 135 can be extended away from the surface of the handle101, and can include a leg 136A at which the retraction member isredirected to the different direction. In other words, the guidingelement 135 may provide a leverage point where as the end user pulls ina first direction from the trauma pathway, the sleeve peels and/orsplits along the horizontal direction generally perpendicular to thepulling direction. The guiding element 135 can be a variety of shapes,such as an elongate body or “L”-shaped, having the leg 136A extendingout from the surface 137 of the handle 101 and a second leg 136Bextending toward the middle to define an opening 138. The opening 138can be configured to allow the retraction member to pass therethrough inorder to lead to the retaining member 120. It is preferable that theopening 138 be sized to allow for movement of the retraction membertherein. The guiding element can confine the retraction member into theopening such that the retraction member is prevented from falling out inthe direction of the first leg and the direction of the second leg. Thefirst legs 136A of a pair of guiding element may be spaced from oneanother in order to confine the removal of the retraction member and thesleeve to a cross-sectional area less than the area of the laceration orthe size of the gap between the vessel portions. This arrangementpermits the retraction member and the sleeve to be removed withoutcontacting or rubbing against the edges of the laceration or the bodyvessel portions to avoid further damage to the vessel.

FIGS. 4A-4B show an another example handle 101, where the distal end ofthe handle may be configured to facilitate the splitting of the sleevealong the split. In one aspect, the surfaces defining the distal end 104can converge toward one another to form a first sharp edge 140 along thedistal end. In addition to, or instead of, the surfaces of the distalend, the lateral surfaces may converge toward one another to form asecond sharp edge 142. When both present, the first and second sharpedges can form a continuous sharp edge. It can be appreciated by thoseskilled in the art that the edges are sharp enough to facilitatesplitting of the sleeve, but not sharp to damage body tissue.

Further appreciation of the tool 100 can be gained with reference toFIGS. 5A-5E, which show the operation of the tool 100 with the system 10loaded at its distal end to define the delivery system 200. FIG. 5Adepicts an example body vessel 220, such as one found in the leg of apatient. The body vessel 220 has previously been subjected to atraumatic episode, resulting in a portion 222 of body vessel 220 beingtorn away or otherwise severely damaged. Pre-surgery preparation hasbeen applied to the leg and a trauma pathway may be formed therein inorder to gain access to the body vessel and the damaged portion thereofAfter clamping the body vessel 220 on both ends of the portion 222 torestrict blood flow temporarily, the body vessel 220 can be cut ortransected by the clinician into two portions 220A, 220B, as shown inFIG. 5B. In one example, the lacerated portion 222 remains withoutrequiring transection and the opening formed thereby can be used forinsertion of the prosthesis. The transection may be at the damagedportion 222 of the blood vessel 220 or as far away as necessary from thedamaged portion to remove unhealthy portions of the body vessel orunrepairable portions of the body vessel. Sutures can be attached to theend openings 225 of the body vessel portions 220A, 220B to keep themfixed in place and opened to facilitate insertion of the prosthesis.Forceps may also be used in a similar manner. Any number of sutures canbe used to retain the end openings 225 in the open position, althoughtriangulation sutures can be sufficient, with each suture being about120 degrees apart from the adjacent suture. A prosthesis is selected tohave a radial expanded cross-section and a longitudinal lengthsufficient to bridge the laceration in the vessel or the gap between thebody vessel portions 220A, 220B and radially fit within the body vesselportions.

According to FIG. 5B, the delivery assembly 200 is shown inserted intothe body through the trauma pathway and positioned at the body vessel.The system 10 with the prosthesis 15 is shown being situated andoriented adjacent the body vessel portions 220A, 220B. The prosthesis 15is in the delivery, compressed configuration, being at least partiallyretained in the radially compressed configuration by the sleeve 30. Thefirst outer end 18 of the prosthesis 15 can be inserted into the vesselportion 220A through the end opening 225 by a sufficient distance toallow the anchoring members of the prosthesis to engage within thetissue. It is preferred that the vessel portion initially selected bethe non-blood supplying vessel end. The vessel portion 220A may bemanually pulled over the first outer end 18 of the prosthesis 15. Theactuation member may be configured with at least two portions, whereretraction of a first portion of the actuation member is configured toretract the sleeve portion associated with the first outer end, andretraction of a second portion of the actuation member is configured toretract the sleeve portion associated with the second outer end. Inother words, the outer ends of the prosthesis may be expandedsimultaneously or in sequence. The sleeve 30 can be removed from thefirst outer end 18 of the prosthesis, such as described herein, whileinserted within the vessel portion 220A. For example, the retractionmember can be retracted in order to peel or split the removable sleeve30 and remove it from the first outer end 18 of the prosthesis to allowfor expansion thereof

In one example, FIG. 5B shows the actuation member 108 in a firstposition. Each of the retraction members, such as the retractionsmembers 46C, 46D of the sleeve 30 is shown gathered at the middle andpositioned through the guiding element 135, along the handle 101, andextending through the retaining member 120 so that the enlarged ends 48are engaged with the retaining member 120. This orientation puts thesystem 10 at the distal end of the tool 100 such that the tip 106 iscontacted with the system 10 at approximately the center. The tip 106can apply a force at approximately the center of the system 10 suitableto retain the system 10 in a substantially fixed position relative tothe tool 100 as the actuation member 108 is moved relative to the system10. The tool 100 can be attached to the system 10 before entry of thesystem 10 within the body, and is inserted within the end opening 225 ofat least one, if not both, body vessel portions 220A, 220B.Alternatively, the system 10, without the tool 100, may first beinserted into the end opening of at least one, if not both, body vesselportions in a manner such that the retraction members can extend outwardthrough the trauma pathway. Here, the retraction members can then becoupled to the tool 100 as described herein.

According to FIG. 5B, the system 10 and the prosthesis 15 can then bemanipulated in order to introduce the second outer end 19 of theprosthesis 15 into the vessel portion 220B through the end opening by asufficient distance to allow the anchoring members of the prosthesis toengage within the tissue. It can be appreciated that the second outerend 19 of the prosthesis may be inserted into the vessel portion 220Bprior to, or subsequent to, the removal of the sleeve 30 from the firstouter end 18. The vessel portion 220B may be manually pulled over thesecond outer end 19 of the prosthesis 15. The sleeve 30 can be removedfrom the second outer end 19 of the prosthesis, such as describedherein, while inserted within the vessel portion 220B to allow forexpansion thereof The vessel portions 220A, 220B can now be sealablyengaged to the first and second outer ends 18, 19 of the prosthesis 15.

In FIG. 5C, after insertion of both outer ends 18, 19 of the prosthesis15 into the respective portions 220A, 220B, the actuation member 108 canbe moved relative to the prosthesis, such as, e.g., within the slot 109from the first position toward the second position. As a result, theretraction members can be moved relative to prosthesis to peel or splitthe sleeve 30. This action removes a portion of the sleeve 30 from therespective outer ends 18, 19 in order to allow for radial expansion ofthe prosthesis 15 at its outer ends. According to FIG. 5D, the actuationmember 108 is in the second position. At this position, the retractionmembers 46C, 46B and the sleeve 30 can be further moved relative to theprosthesis 15 such that the sleeve 30 is entirely removed from theprosthesis. The radial expansion forces of the prosthesis may aid in thesplitting of the sleeve. After full radial expansion of the prosthesis,the system and the sleeve together may be removed from the body.Accordingly, the prosthesis 15 is fully deployed to interconnect thefirst and second vessel portions 220A, 220B of the body vessel 220 toform a conduit for blood flow. The sutures can then be removed.Preferably, portions of the exterior surfaces of the prosthesis sealablyengage with the luminal walls of the body vessel to inhibit leakage ofblood and to force blood to flow throughout the body vessel duringemergency surgery, and particularly to obtain hemostasis or fluidstability while maintaining blood or fluid perfusion. FIG. 5E shows theprosthesis 15 deployed and interconnecting body vessel portions 220A,220B within the leg of the patient. Prosthesis 15 can be adapted forpermanently placement within the patient, thereby obviating a need forsubsequent surgical intervention.

Instead of transecting the vessel, the prosthesis and the distal end ofthe handle can be manipulated in a laceration or opening formed in thewall of the body vessel. The prosthesis may then be repositioned at adesired location with the body vessel. The prosthesis can be expandedwith the assembly 200 such as described herein. Alternatively, thesystem 10 without the tool 100 can be used to deploy a prosthesis. Theclinician would grasp the ends of the retraction member subsequent topositioning within the body vessel portions, and retract the retractionmember ends relative to the prosthesis to allow for expansion of theouter ends of the prosthesis.

FIGS. 6A-6E illustrate an alternative system 300 and delivery method.FIG. 6A depicts the system 300 including a prosthesis 15 retained in aradially compressed configuration within a removable sleeve 310. Apartial cutaway of FIG. 6A shows the various layers of the prosthesis15, such as a support structure 320 and a graft body 322 in relation tothe sleeve 310. To remove the sleeve, the sleeve 310 can be configuredto rapidly weaken, and preferably dissolve entirely, in response toapplication of an activation agent 330 to such configured sleeve. Inother words, the sleeve 310 can be weakened to a degree where the radialexpansion forces of the prosthesis can overcome the retaining forces ofthe sleeve, thereby allowing the prosthesis to move to the radiallyexpanded configuration. Thereafter, the 310 sleeve may continue todissolve in its entirety. In another example, the sleeve can haveperforations. The number, shape, and size of the perforations can beselected for a desired dissolution rate. For example, a sleeve with moreperforations can dissolve at a faster rate than the same sleeve withfewer perforations. The perforations may also allow for improved surfacearea contact, and anchoring, when the prosthesis is expanded in themiddle of the dissolution process of the sleeve.

One example of an activation agent 330 is saline, which is commonlyfound in the emergency room setting. Materials of the sleeve 310 thatdissolve once interfaced with saline include: pullulan which is anextracellular bacterial polysaccharide produced from starch byAureobasidium pullulans; hydroxypropyl methyl cellulose; nonanimal-derived film-forming polymers, for example, polyvinyl alcohol,plant-derived film-forming polymers such as starch, starch derivatives,cellulose, celluloses derivatives other than the HPMC as defined hereinand mixtures thereof, bacterial-derived film-forming polymers such asexo-polysaccharides like xanthan, acetan, gellan, welan, rhamsan,furcelleran, succinoglycan, scleroglycan, schizophyllan, tamarind gum,curdlan, dextran and mixtures thereof; and gelling systems including oneor more cations and/or one or more gelling agents, with cations such asK⁺, Na⁺, Li⁺, NH₄ ⁺, Ca⁺⁺, Mg⁺⁺ and mixtures thereof, and gellingagent(s) such as hydrocolloids such as alginates, agar gum, guar gum,locust bean gum (carob), carrageenans, tara gum, gum arabic, ghatti gum,khaya grandifolia gum, tragacanth gum, karaya gum, pectin, arabian(araban), xanthan, gellan gum, konjac mannan, galactomannan, funoran,and mixtures thereof. It can be appreciated by those skilled in the artthat other activation agents and corresponding sleeve materials can beselected to perform the same function. Other examples include polyethylene glycol, poly ethylene oxide, poly vinylpyrrolidone, aglycosaminoglycan, polysaccharides, polysaccharide derivatives, polyhyaluronic acid, poly alginic acid, chitin, chitosan, chitosanderivatives, hydroxyethyl cellulose, hydroxypropyl cellulose,carboxymethyl cellulose, poly peptides, poly lysine, poly glutamic acid,and proteins, such as albumin.

In one example, a polysaccharide may include tamarind gum (such asxyloglucan polymers), guar gum, chitosan, chitosan derivatives, locustbean gum (such as galactomannan polymers), and other industrial gums andpolymers, which include, but are not limited to, Tara, Fenugreek, Aloe,Chia, Flaxseed, Psyllium seed, quince seed, xanthan, gellan, welan,rhamsan, dextran, curdlan, pullulan, scleroglucan, schizophyllan,chitin, hydroxyalkyl cellulose, arabinan (such as sugar beets),de-branched arabinan (such as from sugar beets), arabinoxylan (such asrye and wheat flour), galactan (such as from lupin and potatoes), pecticgalactan (such as from potatoes), galactomannan (such as from carob, andincluding both low and high viscosities), glucomannan, lichenan (such asfrom icelandic moss), mannan (such as ivory nuts), pachyman,rhamnogalacturonan, acacia gum, agar, alginates, carrageenan, chitosan,clavan, hyaluronic acid, heparin, inulin, cellodextrins, and mixturesthereof Polymers can be crosslinked to improve strength of sleeve and/orsolubitliy of sleeve. Such crosslinking of polymers is described in U.S.Pat. No. 7,960,453, which is incorporated herein by reference in itsentirety. While any water-soluble material, such as cellulosicmaterials, gums, polymers, starches, proteins, and combinations thereofcan be used, an example sleeve is made of glucans because of its highwater solubility and rapid dissolution. Examples of glucans includepullulan and elsinan. It can be appreciated by those skilled in the artthat other activation agents and corresponding sleeve materials can beselected to perform the same function.

The sleeve can be made by the following processes. A solution of thedesired sleeve material can be prepared in a water or saline solution. Amandrel can be dipped into the solution to form a dip coating on themandrel. It is recognized that the sleeve material may be applied byother means to coat the mandrel. Some of the sleeve materials arethermoformable and can be extruded into a tubular segment. Some of thesleeve material can be formed in a sheet that is rolled to form atubular segment. The coated mandrel can be dried in air to form thesleeve. The prosthesis may be radially compressed with a stentcompressor or by other known means in the art. The compressed prosthesiscan be transferred to within the lumen of the sleeve.

The system 300 can be inserted manually through a laceration 339 of abody vessel 340, as shown in FIG. 6B, and then repositioned to besubstantially centered over the laceration, as shown in FIG. 6C. In oneexample, the system 300 can be inserted into two vessel portions of atransected vessel. The activation agent 330 can be applied to the sleeve310 in order to begin the weakening or dissolving process. FIG. 6D showsthe use of a syringe suitably pressurized to release a sufficient amountof the activation agent 330 to rapidly weaken or dissolve sleeve 310.The time to weaken or dissolve the sleeve 310 can depend on the materialand concentration of the sleeve and the activation agent, but it isdesirable that the total time be as quick as possible, e.g., less thanabout 5 to 10 seconds. FIG. 6E shows the prosthesis 15 in the radiallyexpanded configuration engaged with the body vessel 340 after the sleeve310 has dissolved, sealing the laceration 339 from within orinterconnect the two vessel portions, in order to gain hemostasis orfluid stability and still allow blood perfusion or fluid flow.

It can be appreciated by those skilled in the art that specific featuresof each embodiment of the delivery device are interchangeable among thedevice embodiments, even where no references to the specific featuresare made.

Drawings in the figures illustrating various embodiments are notnecessarily to scale. Some drawings may have certain details magnifiedfor emphasis, and any different numbers or proportions of parts shouldnot be read as limiting, unless so-designated in the present disclosure.Those of skill in the art will appreciate that embodiments not expresslyillustrated herein may be practiced within the scope of the presentinvention, including those features described herein for differentembodiments may be combined with each other and/or with currently-knownor future-developed technologies while remaining within the scope of theclaims presented here. It is therefore intended that the foregoingdetailed description be regarded as illustrative rather than limiting.And, it should be understood that the following claims, including allequivalents, are intended to define the spirit and scope of thisinvention.

1. A delivery system comprising: a sleeve configured to retain segmentsof a prosthesis in a compressed configuration, the sleeve having a firstouter segment and a second outer segment associated with a first outerend and a second outer end of the prosthesis, respectively; and a firstretraction member coupled to the first outer segment of the sleeve and asecond retraction member coupled to the second outer segment of thesleeve, wherein, in response to retraction of the first and secondretraction members, the first and second outer segments of the sleeveare removed from the corresponding outer ends of the prosthesis to allowfor expansion of the outer ends of the prosthesis in an outside-indirection.
 2. The system of claim 1, wherein the sleeve is everted suchthat the first and second retraction members are gathered toward amiddle of the sleeve.
 3. The system of claim 1, wherein the first andsecond retraction members are independently retractable.
 4. The systemof claim 1, wherein the sleeve and the retractions members are formedintegrally from a single tubular member.
 5. The system of claim 1,wherein the sleeve comprises a first sleeve member associated with thefirst outer segment of the prosthesis and a second sleeve memberassociated with the second outer segment of the prosthesis.
 6. Thesystem of claim 1, wherein the sleeve comprises a single sleeve disposedover the entire prosthesis.
 7. The system of claim 1, wherein each ofthe retraction members further comprises a first portion and a secondportion separated by a split line.
 8. The system of claim 7, whereineach of the first and second portions of the retraction member comprisesan enlarged end.
 9. A delivery system comprising: a handle; an actuationmember movably attached to the handle; and an assembly disposed at adistal end of the handle, the assembly comprising a sleeve configured toretain segments of a prosthesis in a compressed configuration, thesleeve having a first outer segment and a second outer segmentassociated with a first outer end and a second outer end of theprosthesis, respectively, a first retraction member coupled between thefirst outer segment of the sleeve and the actuation member, and a secondretraction member coupled between the second outer segment of the sleeveand the actuation member, wherein in response to movement of theactuation member relative to the prosthesis from a first position to asecond position, the first and second outer segments of the sleeve areremoved from the corresponding outer ends of the prosthesis to allow forexpansion of the outer ends of the prosthesis.
 10. The system of claim9, wherein each of the retraction members is coupled to the first outersegment of the sleeve at a first attachment point and to the actuationmember at a second attachment point that is closer alignment with amiddle of the prosthesis.
 11. The system of claim 9, wherein theactuation member is movable along a translational axis that is differentthan a longitudinal axis of the prosthesis.
 12. The system of claim 11,wherein the handle comprises a slot formed therein along thetranslational axis, and the actuation member comprises a lever slidablyengaged within the slot of the handle.
 13. The system of claim 11,wherein the handle comprises a guiding member to redirect the retractionmembers from a direction along the longitudinal axis to a differentdirection.
 14. The system of claim 9, wherein the actuation membercomprises a retaining member configured to removably attach with each ofthe retraction members.
 15. The system of claim 14, wherein theretaining member comprises a member having a notch formed therein sizedto receive a portion of the retraction members, the retraction memberscomprise an enlarged end sized larger than the notch.
 16. The system ofclaim 9, wherein the handle comprises an edge configured to facilitatesplitting of the sleeve, wherein a portion of the first and secondretraction members is splittable so that the sleeve has a splittedconfiguration upon movement of each of the first and second retractionmembers together relative to the prosthesis.
 17. The system of claim 9,wherein the handle comprises a distal tip having a concave curvature tocontact the assembly.
 18. A method of open surgical repair of a bodyvessel, comprising: inserting a first outer end of a prosthesis in afirst vessel portion of a body vessel, wherein the first outer end ofthe prosthesis is retained in a compressed configuration with a sleeveportion; inserting a second outer end of the prosthesis in a secondvessel portion, wherein the second outer end of the prosthesis isretained in a compressed configuration with a sleeve portion; andremoving the corresponding sleeve portions from the respective first andsecond outer ends of the prosthesis, whereby the first and second outerends of the prosthesis are allowed to move to an expanded configurationfor engagement with the corresponding vessel portion of the body vessel.19. The method of claim 18, wherein the sleeve portions are coupled toan actuation member movable along a translational axis that is differentfrom a longitudinal axis of the prosthesis, where the removing step isperformed by moving the actuation member along the translational axisfrom a first position to a second position.
 20. The method of claim 18,wherein during the removing step the sleeve portions are dissolvablewith application of an activation agent.